What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists (such as pramipexole and ropinirole), and cholinesterase inhibitors (like rivastigmine and donepezil). Levodopa can cause side effects such as nausea, dizziness, and dyskinesia. Dopamine agonists may lead to side effects including hallucinations, sleep disturbances, and impulse control disorders. Cholinesterase inhibitors can cause gastrointestinal issues like nausea and vomiting, and may worsen tremors. For monoclonal antibodies like prasinezumab, potential side effects could include infusion-related reactions and immune responses, but specific data on prasinezumab's side effects are not yet fully established.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on symptom management rather than disease modification. These include levodopa combined with carbidopa, dopamine agonists like pramipexole and ropinirole, and MAO-B inhibitors such as selegiline. While these treatments alleviate symptoms, they do not slow disease progression. Prasinezumab, a monoclonal antibody targeting alpha-synuclein, is being studied for its potential to modify disease progression, representing a novel approach compared to existing therapies.

What other types of research exist?

Promising novel alternatives to Prasinezumab for Parkinson's Disease patients in 2024 include: 1) Nilotinib, a tyrosine kinase inhibitor that may promote autophagic clearance of alpha-synuclein. 2) Exenatide, a GLP-1 receptor agonist with potential neuroprotective effects. 3) Gene therapies like AAV2-GDNF, which aims to deliver neurotrophic factors directly to the brain. 4) Small molecules such as Anle138b, which inhibit alpha-synuclein aggregation. These alternatives are in various stages of clinical trials and show potential in modifying disease progression.

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Monoclonal Antibodies

Prasinezumab for Early Parkinson's Disease (PADOVA Trial)

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization

Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism

Must not have

Within the last year, unstable or clinically significant cardiovascular disease

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing an IV drug called prasinezumab in people with early-stage Parkinson's Disease who are already on stable medication. The drug aims to slow down the disease by attaching to a harmful protein in the brain. Researchers want to see if it works effectively.

Who is the study for?

This trial is for people with early Parkinson's Disease (PD) who've been diagnosed for 3 months to 3 years, are on stable PD meds, and can use a smartphone app and smartwatch to track symptoms. They should be in the early stages of PD without other neurological diseases or significant health issues like uncontrolled hypertension or recent substance abuse.

What is being tested?

The study tests Prasinezumab, an IV drug against a placebo in participants with early-stage PD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo. Participants must be on stable PD medication throughout the study.

What are the potential side effects?

While specific side effects aren't listed here, monoclonal antibodies like Prasinezumab can cause allergic reactions, infusion-related reactions (like fever or chills), and possibly affect liver function based on required lab test monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's is in the early stages (I or II) without medication.

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I have been diagnosed with Parkinson's disease based on movement symptoms.

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My Parkinson's disease medication will stay the same during the study.

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I have no motor complications from Parkinson's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had serious heart problems in the past year.

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My high blood pressure is not under control.

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I have been diagnosed with Parkinson's disease dementia.

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I have a significant neurological condition that is not Parkinson's disease.

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My condition is a type of Parkinson's disease that is not the common form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PrasinezumabExperimental Treatment1 Intervention

Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo as an IV infusion Q4W.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Parkinson's Disease treatments often target the dopaminergic system to manage symptoms. Levodopa, a precursor to dopamine, is commonly used to replenish dopamine levels in the brain. Dopamine agonists mimic dopamine's effects, while MAO-B inhibitors prevent dopamine breakdown. Prasinezumab, a monoclonal antibody, targets alpha-synuclein, a protein that aggregates and contributes to neurodegeneration in PD. By potentially slowing the spread of alpha-synuclein pathology, Prasinezumab aims to modify disease progression, offering hope for long-term management beyond symptomatic relief. This is crucial for PD patients as it addresses the underlying disease mechanism, potentially improving quality of life and slowing disease advancement.

From the Gut to the Brain and Back: Therapeutic Approaches for the Treatment of Network Dysfunction in Parkinson's Disease.